In Vitro Maturation (IVM) of Human Oocytes

Collection of one mature egg from a follicle in the ovary without gonadotropin medications
(natural cycle IVF) results in low pregnancy rates. One way to improve natural cycle IVF is
to combine this procedure with the removal of immature eggs from the ovary and mature these
eggs in the laboratory ( in vitro maturation-IVM). The in vitro mature eggs are fertilized
and the resultant embryos are cultured using conventional IVF techniques.

Inclusion Criteria:

1. Each subject must be female.

2. Each subject must have an indication for COH and IVF with or without ICSI.

3. Each subject must be willing and able to provide written informed consent for the
trial

4. Each subject must be 25 to ≤42 years of age at the time of signing informed consent.

5. Each subject must have a normal cervical smear result (no atypical or abnormal cells,
or in case of atypical squamous or glandular cells, no signs of malignancy;
corresponding to Papanicolaou [PAP] I or II) obtained within 12 months prior to
signing informed consent must be available

Exclusion Criteria:

1. Subject with premature ovarian failure

2. Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid
dysfunction

3. Subject with malformation or absence of uterus

4. Subject has tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by
local laboratory; results obtained within 1 year prior to signing ICF are considered
valid).

5. Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and
progesterone